UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040444 |
|---|---|
| Receipt number | R000046156 |
| Scientific Title | Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx |
| Date of disclosure of the study information | 2020/05/20 |
| Last modified on | 2021/06/02 13:46:12 |
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Basic information
Public title
Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Acronym
DREX Study
Scientific Title
Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Scientific Title:Acronym
DREX Study
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship between the grade of diabetic retinopathy and visual function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual function measured by EvokeDx
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults and Diabetic patients who have best-corrected visual acuity better than 0.7 in decimal.
Key exclusion criteria
Patients with diabetic macular edema, galucoma, and who had been treated diabetic retinopathy within 12 weeks. If the researchers found the person not suitable for the study, the person will be excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
St Luke's International Hospital
Division name
Department of Ophthalmology
Zip code
1048560
Address
9-1 Akashicho Chuoku Tokyo Japan
TEL
03-3451-5151
ozaway@luke.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | Department of Ophthalmology |
| Last name | Ozawa |
Organization
St Luke's International Hospital
Division name
Department of Ophthalmology
Zip code
1048560
Address
9-1 Akashicho Chuoku Tokyo Japan
TEL
03-3451-5151
Homepage URL
ozaway@luke.ac.jp
Sponsor or person
Institute
St Luke's International University
Institute
Department
Personal name
Funding Source
Organization
SENJU PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of St Luke's International Hospital
Address
9-1 Akashicho Chuoku Tokyo Japan
Tel
03-3451-5151
kenkyukikaku@luke.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
NONE
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046156
